A pre-visit questionnaire and guided conversation to improve survivorship care in oncology outpatient visits
Official title: FRAME (Focused Recognition, Assessment and Management of Late Effects): A Single-Center Implementation Study Using RE-AIM to Guide Evaluation in the Department of Oncology, Vejle Hospital
Run by Vejle Hospital · NCT07281820 · Data updated 2026-11-12
This project tests whether a short pre-visit questionnaire plus a guided conversation and tailored follow-up can help cancer survivors and their clinicians manage late effects during routine oncology outpatient visits.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Vejle Hospital Academic / other |
| Locations | 1 site (Vejle, Region Syddanmark) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | December 15, 2025 |
| Trial ID | NCT07281820 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are cancer survivors attending outpatient oncology visits at Vejle Hospital who can complete the pre-visit FRAME-PRO questionnaire and participate in a guided discussion with their clinician.
✕Probably not a fit
Patients who do not receive care at Vejle Hospital, cannot use the electronic app, or require acute inpatient care are unlikely to benefit from this outpatient implementation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
FRAME embeds a patient-reported questionnaire (FRAME-PRO) into routine oncology outpatient visits so patients and informal caregivers can reflect on late effects before the appointment. Clinicians use the FRAME-PRO responses during the visit to prioritize concerns, triage severity, and co-create a documented management plan with stepped referrals across primary care, hospital supportive services, and specialized late-effects clinics. Implementation strategies draw on ERIC methods (education, audit and feedback, reminders, local champions, technical assistance) and the project measures implementation with the RE-AIM framework supplemented by Proctor implementation outcomes. Data come from the Mit Sygehus app, departmental registries, bespoke questionnaires, fidelity checklists, and qualitative interviews, with quantitative summaries and content analysis of qualitative data.
Why it matters
Potential benefit: If successful, FRAME could make survivorship visits more focused on what matters to patients, increase appropriate referrals, and improve coordination of late-effects care.
How similar studies have gone: PRO-based care models in oncology have improved symptom recognition and service use in prior studies, but applying them specifically to survivorship care and cross-sector management in routine outpatient clinics is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- All oncologists conducting outpatient visits at the Department of Oncology, Vejle Hospital during the study period. Exclusion Criteria: \- None. Participants for interviews: * A purposive sample of patients, informal caregivers, and clinicians approached ≥6 months after launch * written and verbally informed consent.
Where it's running
-
Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark
Vejle, Region Syddanmark, Denmark Recruiting
Study contacts
- Study coordinator: Johanne D Lyhne, PhD
- Email: JOHANNE.DAM.LYHNE@RSYD.DK
- Phone: 004522910740
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Understanding the long-term effects of pediatric germ cell tumors
This study is trying to understand the long-term effects of treatment on kids and teens who survived germ cell tumors to see how their health might change over time.
-
Assessing late effects in childhood cancer survivors in Aarau, Switzerland
This study looks at the long-term health effects that childhood cancer survivors experience after their treatment to help improve their follow-up care.
-
Gyrotonic exercise for elders with breast cancer and Behcet disease
We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.
-
PECS II vs SPSIP nerve blocks for pain after mastectomy
This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
Compare a new endoscopy-assisted breast-conserving surgery with the usual approach
This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.